Z-2256-2018 Class II Terminated
FDA device recall Z-2256-2018 was initiated by PENTAX of America Inc on March 30, 2018 and is designated Class II. Reason for recall: The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the cont… The recall status is terminated (terminated April 28, 2021). Affected quantity: 57 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- March 30, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 units
Product Description
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Reason for Recall
The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
Distribution Pattern
Distribution US nationwide.
Code Information
Lot Codes: 02132018-01 & 02162018-03